Rationale and design of the pullback pressure gradient (PPG) global registry.
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Munhoz Daniel, Collet Carlos, Mizukami Takuya, Yong Andy, Leone Antonio Maria, Eftekhari Ashkan, Ko Brian, da Costa Bruno R, Berry Colin, Collison Damien, Perera Divaka, Christiansen Evald Høj, Rivero Fernando, Zimmermann Frederik M, Ando Hirohiko, Matsuo Hitoshi, Nakayama Masafumi, Escaned Javier, Sonck Jeroen, Sakai Koshiro, Adjedj Julien, Desta Liyew, van Nunen Lokien X, West Nick E J, Fournier Stephane, Storozhenko Tatyana, Amano Tetsuya, Engstrøm Thomas, Johnson Thomas, Shinke Toshiro, Biscaglia Simone, Fearon William F, Ali Ziad, De Bruyne Bernard, Johnson Nils P
Аннотация
AIM: The primary objective is to determine the predictive capacity of the PPG for post-PCI FFR.
METHODS: This prospective, large-scale, controlled, investigator-initiated, multicenter study is enrolling patients with at least 1 lesion in a major epicardial vessel with a distal FFR ≤ 0.80 intended to be treated by PCI. The study will include 982 subjects. A standardized physiological assessment will be performed pre-PCI, including the online calculation of PPG from FFR pullbacks performed manually. PPG quantifies the CAD pattern by combining several parameters from the FFR pullback curve. Post-PCI physiology will be recorded using a standardized protocol with FFR pullbacks. We hypothesize that PPG will predict optimal PCI results (post-PCI FFR ≥ 0.88) with an area under the ROC curve (AUC) ≥ 0.80. Secondary objectives include patient-reported and clinical outcomes in patients with focal vs. diffuse CAD defined by the PPG. Clinical follow-up will be collected for up to 36 months, and an independent clinical event committee will adjudicate events.
RESULTS: Recruitment is ongoing and is expected to be completed in the second half of 2023.
CONCLUSION: This international, large-scale, prospective study with pre-specified powered hypotheses will determine the ability of the preprocedural PPG index to predict optimal revascularization assessed by post-PCI FFR. In addition, it will evaluate the impact of PPG on treatment decisions and the predictive performance of PPG for angina relief and clinical outcomes.